Pfizer Announces Positive Phase 3 Results of ADCETRIS Regimen in DLBCL

Pfizer announced that a Phase 3 study of the antibody-drug conjugate ADCETRIS (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to lenalidomide and rituximab plus placebo. Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).
 
The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials. Full data will be submitted for presentation at an upcoming medical meeting.
 
DLBCL is the most common type of lymphoma and is a fast-growing, aggressive blood cancer. Approximately 40% of patients with DLBCL do not respond to initial treatment or develop relapsed disease after first-line treatment.
 
ADCETRIS is a standard of care for patients with certain lymphomas and is approved for seven indications in the U.S with more than 55,000 patients treated since its first U.S. approval in 2011. More than 140,000 patients have been treated with ADCETRIS globally. Pfizer plans to share the ECHELON-3 data with the U.S. FDA to potentially support regulatory filing in the U.S.
 
Pfizer gained access to Adcetris with its $43 billion acquisition of Seagen in March 2023.
Adcetris was first approved in August 2011 for the treatment of Hodgkin lymphoma and the rare systemic anaplastic large cell lymphoma. Adcetris is being developed in other subtypes and stages of Hodgkin lymphoma, peripheral T-cell lymphoma, non-small cell lung cancer and melanoma.